Quality of minor surgery carried out in primary or secondary care: population based randomised controlled equivalence trial
| ISRCTN | ISRCTN51268626 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51268626 |
| Secondary identifying numbers | HTA 95/25/03 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 21/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Steve George
Scientific
Scientific
University of Southampton Clinical Trials Unit
Mailpoint 131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 8079 6533 |
|---|---|
| pluto@soton.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | A prospective randomised comparison of minor surgery in primary and secondary care |
| Study acronym | MiSTIC (Minor Surgery Trial In the Community) |
| Study objectives | Increasingly with the move towards a "primary care led NHS" services previously provided within hospitals are being provided within primary care settings. One such service is minor surgery. Although minor surgery is widely practised in primary care it has not been subjected to critical analysis in a randomised study in terms of its safety, quality and cost effectiveness. This study is a prospective, randomised controlled trial comparing the treatment of minor surgical conditions in primary and secondary care in terms of these variables. Please note that the target number of participants was added as of 02/12/2008. |
| Ethics approval(s) | South and West Regional Research Ethics Committee, approved on 06/10/1999 (ref: 092/99) |
| Health condition(s) or problem(s) studied | Lesions requiring minor surgery (predominantly skin) |
| Intervention | Interventions amended as of 02/12/2008: Elective minor surgeries in the categories described in the participants inclusion criteria field, delivered either in primary care, by the patient's own GP or by referral to a primary care colleague, or in hospital, by either surgeons or dermatologists at a variety of grades. Previous interventions: Quality of surgery performed in primary care vs surgery performed in hospital |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Primary outcome measures amended as of 02/12/2008: Quality of treatment measured using cosmetic results of surgery. Previous primary outcome measures: Safety, quality and cost effectiveness. |
| Secondary outcome measures | Added as of 02/12/2008: 1. Extent to which samples were sent for histology 2. Completeness of excision of malignant lesions 3. Patient satisfaction with aspects of care |
| Overall study start date | 01/05/1999 |
| Completion date | 30/04/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 490 |
| Key inclusion criteria | Inclusion criteria amended as of 02/12/2008: All patients (both genders, no age limits) with one of a range of conditions amenable to minor surgery who were considered suitable for treatment by a participating GP or one of their partners. The study focuses on four categories of minor surgical treatment; excisions, incisions, aspirations and "other", including removal of foreign bodies. Previous inclusion criteria: Patients requiring minor surgery. |
| Key exclusion criteria | Added as of 02/12/2008: 1. Patients whom operating doctor considered too complex for treatment in primary care 2. Patients requiring cautery 3. Patients requiring injections for the treatment of painful joints |
| Date of first enrolment | 01/05/1999 |
| Date of final enrolment | 30/04/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Southampton Clinical Trials Unit
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
University of Southampton (UK)
University/education
University/education
Highfield
Southampton
SO17 1BJ
England
United Kingdom
| Phone | +44 (0) 23 8059 5000 |
|---|---|
| rgoinfo@soton.ac.uk | |
| Website | http://www.soton.ac.uk/ |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2008 | Yes | No |
